Process Engineer 1

Your Role 

The Process Engineer is responsible for supporting the manufacturing and testing of membranes used in high-purity filtration products while maintaining a strong focus on safety, quality, process control, electro-mechanical assembly, and material handling. You will establish and optimize operating specifications, implement process improvements, and troubleshoot manufacturing issues to improve efficiency, product quality, and overall performance. You will monitor machinery, automated equipment, and manufacturing processes, investigate complex production challenges, identify root causes, and implement corrective actions to ensure reliable operations. Working closely with Manufacturing, Quality, Maintenance, and other cross-functional teams, you will help drive process stability, evaluate product quality, reduce waste, improve yields and productivity, and support continuous improvement initiatives within a regulated manufacturing environment. 

Duties Include 

• Responsible for maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.  

• Exchanges ideas with other team members and participates leads technical discussions in to realize process improvements and changes.  

• Provides basic leads process support on assigned Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA), implementing robust solutions to address root cause of issues.  

• Responsible for generating, reviewing, and approving engineering, manufacturing, and quality procedures necessary to support production operation, equipment validation/revalidation, and product launch.  

• Ensures adherence to Current Good Manufacturing Practices (cGMP).  

• Leads and implements basic level changes to reduce process waste and variation, and improve yields leads yield improvement and product performance initiatives.  

• Generates capital requests to support new processes and capital equipment purchase.  

• Generates capital requests for new processes and equipment, leads and participates in equipment and process validation activities (including protocol/report development, review, and execution), and manages change requests by initiating, reviewing, and approving, implementing solutions to support operational needs. 

• Works collaboratively with cross-functional teams, takes ownership of project tasks and deadlines, and conducts basic process engineering assessments using data to make informed product disposition decisions. 

• Reviews capital equipment fabrication activities to ensure manufacturing, installation, and operational testing conform to industry standards, and user requirements.  

This is a week-end position working 3 x 12-hour shifts Saturday, Sunday, and one weekday of choice.  

Who You Are 

Minimum Qualifications 

• Bachelor’s degree in chemical engineering, electrical engineering, mechanical engineering, business management, computer science or other life science discipline. 

OR 

• High School diploma and 8+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.  

Preferred Qualifications 

• Master of Science Degree in Electrical, Mechanical, Chemical or Industrial Engineering.   

• Basic Electro-Mechanical, instrument and pneumatic knowledge along with 2+ years of experience applying this knowledge to process/equipment design and/or troubleshooting.  

• Proven ability to analyze data sets, apply statistical analysis principles, and clearly summarize conclusions/results.  

• Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.  

• Read and understand basic mechanical and electrical drawings and P&ID’s.  

• Experience with Microsoft products, Minitab, and CAD software packages.  

• Demonstrates a strong foundation in safe work practices (including lockout/tagout and electrical safety), Lean/Six Sigma experience (Green or Black Belt), excellent communication skills, hands-on expertise with automated fluid skids, web processes, and process development, as well as experience in Process Safety Management and Class I Division 1 environments. 

Pay Range for this position: $72,600.00 - $110,700 .00 Annually  

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement 

RSREMD